Executive Director, Global Regulatory Affairs CMC Devices and Drug-Device Combination Product
Takeda
June 26, 2026
Remote friendly (Boston, MA)
United States
$238,000 - $374,000 USD yearly
Corporate Functions
Responsibilities:
- Provide strategic leadership for global regulatory affairs of medical devices and drug-device combination products; oversee global regulatory strategy and major submissions to maximize approvals/clearance timelines.
- Build regulatory best practices and a cross-functional regulatory community across device/combination product, quality, clinical, development, and manufacturing interfaces.
- Lead and develop regulatory leaders/SU teams; ensure high-quality execution and timely lifecycle compliance for submissions (e.g., IDE, 510(k), De Novo, PMA, CE marking/MDR technical documentation, variations/changes, vigilance).
- Partner with cross-functional teams to align evidence generation, usability/human factors, risk management, and value messaging to regulatory and access requirements.
- Anticipate and mitigate regulatory risks in line with ISO 14971/design controls and applicable global regulations.
- Represent Global Regulatory Affairs with senior governance and global regulators/notified bodies (e.g., FDA, EU MDR authorities, MHRA, PMDA).
- Lead initiatives improving regulatory strategy, operational excellence, and quality systems interfaces; influence without authority.
- Provide regulatory strategy leadership for business development/due diligence (classification, pathways, evidence, lifecycle obligations).
Minimum qualifications:
- Advanced degree (MS/PhD/PharmD) in scientific or engineering discipline.
- 20+ years industry experience; 10+ years in Regulatory Affairs with demonstrated leadership in medical devices and/or drug-device combination products.
- Significant experience leading/reviewing/authoring/managing device/combination product regulatory submissions and deficiency responses.
- Strong working knowledge of FDA and EU MDR/IVDR; post-market/vigilance obligations (other regions a plus).
- Ability to interpret complex technical/nonclinical/clinical/manufacturing issues and provide expert guidance (technical documentation/DHF, design controls, human factors/usability, biocompatibility, software/cybersecurity as applicable, post-market lifecycle planning).
- Strong communication, negotiation, timeline management; global teamwork.
Benefits (explicitly listed): Medical/dental/vision, 401(k) w/ match, disability, life insurance, tuition reimbursement, paid volunteer time off, holidays, well-being benefits; up to 80 hours sick time and up to 120 hours paid vacation for new hires; possible incentives.
Base salary (location-specific): $238,000–$374,000 (Boston, MA).
- Provide strategic leadership for global regulatory affairs of medical devices and drug-device combination products; oversee global regulatory strategy and major submissions to maximize approvals/clearance timelines.
- Build regulatory best practices and a cross-functional regulatory community across device/combination product, quality, clinical, development, and manufacturing interfaces.
- Lead and develop regulatory leaders/SU teams; ensure high-quality execution and timely lifecycle compliance for submissions (e.g., IDE, 510(k), De Novo, PMA, CE marking/MDR technical documentation, variations/changes, vigilance).
- Partner with cross-functional teams to align evidence generation, usability/human factors, risk management, and value messaging to regulatory and access requirements.
- Anticipate and mitigate regulatory risks in line with ISO 14971/design controls and applicable global regulations.
- Represent Global Regulatory Affairs with senior governance and global regulators/notified bodies (e.g., FDA, EU MDR authorities, MHRA, PMDA).
- Lead initiatives improving regulatory strategy, operational excellence, and quality systems interfaces; influence without authority.
- Provide regulatory strategy leadership for business development/due diligence (classification, pathways, evidence, lifecycle obligations).
Minimum qualifications:
- Advanced degree (MS/PhD/PharmD) in scientific or engineering discipline.
- 20+ years industry experience; 10+ years in Regulatory Affairs with demonstrated leadership in medical devices and/or drug-device combination products.
- Significant experience leading/reviewing/authoring/managing device/combination product regulatory submissions and deficiency responses.
- Strong working knowledge of FDA and EU MDR/IVDR; post-market/vigilance obligations (other regions a plus).
- Ability to interpret complex technical/nonclinical/clinical/manufacturing issues and provide expert guidance (technical documentation/DHF, design controls, human factors/usability, biocompatibility, software/cybersecurity as applicable, post-market lifecycle planning).
- Strong communication, negotiation, timeline management; global teamwork.
Benefits (explicitly listed): Medical/dental/vision, 401(k) w/ match, disability, life insurance, tuition reimbursement, paid volunteer time off, holidays, well-being benefits; up to 80 hours sick time and up to 120 hours paid vacation for new hires; possible incentives.
Base salary (location-specific): $238,000–$374,000 (Boston, MA).